Device recall: Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials Provided: 1. Test Device 2. Lancet 3. Alcohol…
Class I FDA enforcement event 70668. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Lusys Laboratories, Inc. started this device recall on 13 Mar 2015. The firm address in the FDA record is in San Diego, CA. FDA put the recall in Class I. FDA event 70668 has 8 product records. The first FDA enforcement report date is 15 Apr 2015. The record gives the status Terminated, with the termination date 31 May 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.
Recalling firm
Lusys Laboratories, Inc., San Diego, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
8 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1328-2015 | Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials Provided: 1. Test Device 2. Lancet 3. Alcohol pad. 4. Develop buffer tube contain buffer vial (0.3ml) | 1,055 units | Class I | Terminated | 15 Apr 2015 |
| Z-1329-2015 | Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged separately, and sufficient for use with up to 40 tests. | 1,015 units | Class I | Terminated | 15 Apr 2015 |
| Z-1330-2015 | Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged | 80 units | Class I | Terminated | 15 Apr 2015 |
| Z-1331-2015 | Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit | 40 units | Class I | Terminated | 15 Apr 2015 |
| Z-1332-2015 | Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit | 20 units | Class I | Terminated | 15 Apr 2015 |
| Z-1333-2015 | Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial(0.5ml) for feces test 4. Swab for Nasal test. | 20 units | Class I | Terminated | 15 Apr 2015 |
| Z-1334-2015 | Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial (0.5ml) for feces test 4. Swab for Nasal test. | 5 units | Class I | Terminated | 15 Apr 2015 |
| Z-1335-2015 | Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit | 40 units | Class I | Terminated | 15 Apr 2015 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2015
- 1,153
- Share of these events in Class I
- 4%
- Product records in this event
- 8Median of the firm: 8
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 13 Jan 2022 | LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test) | Device | Class I | 3 |
Official channels
- FDA enforcement report Z-1328-2015The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 70668. https://recallregister.com/fda/i/70668/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.
- What quantity of product is in FDA event 70668?
- The event has 8 product records. The first record gives this quantity:
1,055 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2015 have the same class?
- 4% of the 1,153 device events that started in 2015 are in Class I.